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Three Year Follow-Up Data from Phase 3 CROWN Trial of Pfizer’s LORBRENA (lorlatinib) Confirm Prolonged Progression-Free Survival in First-Line ALK-Positive Advanced Lung Cancer

Pfizer Inc. (NYSE: PFE) announced updated results from the Phase 3 CROWN trial, which evaluated LORBRENA (lorlatinib, available in Europe under the brand name LORVIQUA) versus XALKORI (crizotinib) in people with previously untreated anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC).

This analysis reported after a median follow-up of three years, LORBRENA continued to demonstrate meaningful improvement in progression-free survival (PFS) assessed by blinded independent central review (BICR), the primary endpoint, compared to XALKORI (HR, 0.27; 95% CI, 0.18–0.39), corresponding to a 73% reduction in the rate of progression or death. These data will be presented on April 12, 2022, at the American Association for Cancer Research (AACR) Annual Meeting 2022 (Abstract # CT223 / 2), Pfizer said in its press release.

“The long-term results from the CROWN trial confirm LORBRENA’s compelling safety and efficacy profile in the first-line setting, providing sustained benefit for up to three years for this patient population,” said Chris Boshoff, M.D., Ph.D., Chief Development Officer, Oncology, Pfizer Global Product Development. “Since its first-line approval based on the initial groundbreaking CROWN trial results, LORBRENA has solidified its place as a practice-changing medicine, and these updated data add to the growing body of evidence supporting its use from the onset of metastatic disease.”

“Approximately 25-40% of people with ALK-positive advanced non-small cell lung cancer either have brain metastases at diagnosis or develop brain metastases within two years after initial diagnosis, and biomarker-driven medicines like LORBRENA have transformed the way we treat this typically aggressive disease,” said Professor Benjamin Solomon, MBBS, Ph.D., Department of Medical Oncology at the Peter MacCallum Cancer Centre in Melbourne, Australia. “The new results from the CROWN trial confirm LORBRENA as a treatment option that significantly improves outcomes for people with previously untreated ALK-positive advanced NSCLC.”


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